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# a-BASF The Chemical Company 

### Helping Make Products Better"P,MI·':-,. 

## 111=55 August 10, 2010

Via Federal Express United States Environmental Protection Agency - East Attn: TSCA Section 8(e) Room 6428 1201 Constitution Avenue, NW Washington, DC 20004 

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### Subject: Notice in Accordance with Section 

### 8(e): Results of DECD 421 Reproduction/Developmental Toxicity Screening Test in Wistar Rats with 3-Dimethylaminopropyl oleic acid amide (CAS No, 109-28-4) Dear Sir/Madam: BASF Corporation is submitting results of OECD 421 Reproduction/ Developmental Toxicity Screening Test in Wistar rats [Crl:WI(HAN)] with 3-Dimethylaminopropyl oleic acid amide (CAS No. 109-28-4), conducted by BASF SE, Ludwigshafen, Germany. The aim of this study was to obtain information on the possible effects of 3-Dimethylaminopropyl oleic acid amide on the integrity and performance of the male and female reproductive systems including gonadal function, mating behavior, conception, gestation and parturition. The study was carried out with reference to the requirements of the following guidelines: • OECD Guidelines for Testing of Chemicals; No. 421, Reproduction/Developmental Toxicity Screening Test (27 Jul 1995) EPA, Health Effects Test Guidelines; OPPTS 870.3550: Reproduction/Developmental Toxicity Screening Test (JuI2000) The dose levels were 0; 25, 75 and 200 mg/kg body weight/day. All FO parental animals were treated by gavage beginning on the first day of the premating period. All animals were observed daily for any clinical signs during the study period. After a 14-day premating period, the male and female parental animals were mated overnight in a 1:1 ratio until evidence of copulation (vaginal smear). The day on which sperm was detected was referred to as gestation day (GD) 0 and the following day as GD 1. All parental males were sacrificed and examined after the end of the administration period (at least 28 days). The parental females were allowed to deliver and rear their pups until postnatal day (PND) 4. On PND 4, all pups were sacrificed and examined.

BASF Corporation 100 Campus Drive Florham Park, NJ 07932 Tel: (800) 526-1072 www.basfcom/usa 

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# BASF The Chemical Company
United States Environmental Protection Agency - East August 10, 2010 Page 2
The following is a summary of the most relevant results: Test group 3: 200 mg/kg body weight/day FO parental animals
• Clinical Examinations: o Eyelid halfclosure in 1 male animals in the first week of treatment o Eyelid halfclosure and piloerection temporarily in 1 female animal during gestation and lactation. o Decreased body weight gain in male animals in the first week of treatment (53%) • Pathology: o Decreased absolute terminal body weights in males (95%) F1 pups o Viability index decreased significantly by 6%
Test group 2: 75 mg/kg body weight/day FO parental animals
• ClinicalExaminations: o Salivation before treatment in one male animal in treatment week 3.

• Pathology: o Decreased absolute terminal body weights in males (96%) F1 pups o No test-substance related, adverse findings were observed.
Test group 1: 25 mg/kg body weight/day FO parental animals
• Clinical Examinations: o No test-substance related, adverse findings were observed.

• Pathology: o No test-substance related, adverse findings were observed. F1 pups o 

### No test-substance related, adverse findings were observed. BASF Corporation 100 Campus Drive Florham Park, NJ 07932 Tel: (800) 526-1072 www basf.com/usa

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# ·BASF
The Chemical Company

United States Environmental Protection Agency - East August 10, 2010 Page 3

BASF Corporation understands that reporting of the results from this study underTSCA 8(e) is in accordance with EPA's policy. If you have any questions, please call Janet Cerra at (973) 245-6693. Sincerely,

Janet Cerra Product Regulatory Center of Expertise North America 1094th Letter.doc

BASF Corporation 100 CampusDrive Florham Park,NJ07932 Tel: (800) 526-1072 wwwbasf.com/usa

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From: Origin ID:LKKA (973)245-6693

### ~e Ship Date: 10AUG10 JanetCerra ActWgt 1.0LB BASF Express CAD: 448753311NET3060 100Campus Drive Delivery Address Bar Code FlorhamPark,NJ07932 1111111111111111111111111111111111111III J18211005250225 SHIPTO: (202)564-8930 BILLSENDER Ref# US635018 

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